FDA Sued Over Approval of Antibiotics in Animal Feed

On May 25, 2011, the Natural Resource Defense Council (NRDC), a coalition of health and consumer organizations, filed suit against the U.S. Food and Drug Administration (FDA) regarding its regulation of antibiotics used in animal feed. The complaint alleges that the FDA has failed to withdraw the approval of antibiotics in animal feed for nontherapeutic uses that are not shown to be safe. The complaint comes as the FDAs regulation of antibiotics in food animals has been under increased scrutiny. Please see our previous report for more information regarding FDA regulation of animal antibiotics.

According to the complaint, the FDA concluded in 1977 that the nontherapeutic use of penicillin and tetracyclines in animal feed was not shown to be safe and the drugs were contributing to the development of antibiotic-resistant bacteria that could be transferred to humans. Additionally, two of the plaintiffs submitted citizen petitions, in 1999 and 2005, requesting the FDA withdraw approval. However, the agency has not issued a final response to either petition. Pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA is required to withdraw approval for animal drugs if the drugs are not shown to be safe for the uses for which they were approved. 21 U.S.C. 360b(e)(1).

The NRDC seeks to compel the FDA to take action on the agencys own safety findings, withdraw approval for most nontherapeutic uses of penicillin and tetracyclines in animal feed, and respond to the citizen petitions filed by several of the plaintiffs.

Fuerst Ittleman will continue to monitor the progress of this lawsuit and the FDAs regulation of antibiotics in animal feed. For more information, please contact us at contact@fuerstlaw.com.

This entry was posted on Tuesday, August 2nd, 2011 at 6:57 am and is filed under FDA.

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